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    Life Sciences

    Clinical Pharmacology Podcast with Nathan Teuscher

    I discuss clinical pharmacology and pharmacometrics topics from the perspective of drug development scientists. I share my expertise and knowledge about designing and conducting clinical pharmacology studies and discuss how to analyze the data using the most effective approaches. I draw from my experience of over 20 years working in drug development organizations and consultancies.

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    Copyright: © Nathan Teuscher

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    Latest Episodes:
    What should you use to present PK results? (Ep. 31) Aug 12, 2024
    Show notes

    In this episode I discuss different methods of presenting pharmacokinetic and pharmacometrics results. I spoke about using PowerPoint and R Markdown derived HTML files. While I prefer HTML files in nearly all cases, I appreciate that sometimes PowerPoint format is required by some companies. I included multiple suggestions for both PowerPoint and HTML files that can help make the information presentation more effective.


    Links discussed in the show:

    • Floating table of contents in R Markdown HTML output
    • How to include CSS in your R Markdown
    • Creating tabs in R Markdown
    • Code folding in R Markdown
    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved

    How important is terminal rate constant? (Ep. 30) Jul 22, 2024
    Show notes

    This episode covers the terminal elimination rate constant calculated using non-compartmental analysis techniques. I reviewed how the rate constant is used to estimate half-life and extrapolate AUC to infinity, reviewed the methods for calculating the terminal rate constant value, and some important points about sample selection. Finally, I gave my reasons that we should ultimately stop talking about this and fretting over the method of calculation. Instead, let’s design better PK experiments with more optimal sampling to capture decline of the drugs we are studying.


    Links discussed in the show:

    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter

    Copyright Teuscher Solutions LLC

    All Rights Reserved

    Parellelization in modeling (Ep. 29) Jul 08, 2024
    Show notes

    This episode covered parallelization in modeling analyses. I spoke about across model parallelization and within model parallelization. I recommended some approaches for choosing how many cores to use in parallelization and also discussed different modeling computer systems you can use.


    Links discussed in the show:

    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved

    Residual errors and submission packages (Ep. 28) Jun 24, 2024
    Show notes

    Today I covered 2 different topics. First, I spoke about residual error models when modeling. I discussed additive, proportional, and power models. I also reviewed combined models and when they can be helpful. Then I spoke about modeling report submission packages. I explained what I put in those packages, how they are used, and some potential changes coming in the future.


    Links discussed in the show:

    • Publication on model master file
    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved


    Simulations (Ep. 27) Jun 10, 2024
    Show notes

    This episode discusses simulations. I group simulations into 4 categories: (1) average response, (2) population, (3) individual, and (4) clinical trial simulations. I discuss details of each of these types of simulations and the different variability terms included in each one. I strongly recommend that we implement more clinical trial simulations in our work. This will help us design and execute more successful clinical trials that take advantage of our existing knowledge about a drug. Enjoy the show and connect with me using the links below if you have any questions.


    Links discussed in the show:

    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved

    Different work environments (Ep. 26) May 27, 2024
    Show notes

    Today’s show is about different work environments and not scientific topics. Throughout my career I have worked in many different types of companies, and I would like to share some observations with you from those experiences. I have held positions at startup companies or small biotechnology companies, large pharmaceutical companies, contract research laboratories, consulting firms, and working for myself as a consultant, and now as a software developer. Although my work has been focused on clinical pharmacology and pharmacometrics, the jobs and work environments are very different.


    Links discussed in the show:

    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved

    Biosimilar products (Ep. 25) May 13, 2024
    Show notes

    Today’s show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary comparisons to the reference product. I review requirements for PK similarity, PD similarity, immunogenicity, and safety. I also touch on the idea of interchangeability between the biosimilar and reference products.


    Links discussed in the show:


    • FDA Guidance on Clinical Pharmacology Data to support Biosimilarity (May 2016)
    • FDA Guidance on Demonstrating Interchangeability (May 2019)
    • FDA Q&A on Biosimilarity and Interchangeability (Sep 2023)
    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved


    Choosing an absorption model (Ep. 24) Apr 22, 2024
    Show notes

    Today’s show discussed approaches for modeling absorption profiles. I discussed the rationale behind modeling absorption and then described some common models. These included first-order absorption, zero-order absorption, transit compartments, distributed delay, Weibull, and zero/first order absorption. I also provided my recommendations on how to model absorption.


    Links discussed in the show:

    • Distributed delay modeling in PK and PD
    • Modeling biphasic formulation of methylphenidate
    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved

    What is Aplos NCA? (Ep. 23) Apr 08, 2024
    Show notes

    Today’s show was an overview of Aplos Analytics and the development story for Aplos NCA. Please consider participating in the Early Access Program. Use the link below to learn more about Aplos NCA.

    Links discussed in the show:

    • Aplos Analytics website
    • Aplos Analytics Contact Us Page
    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved


    Big announcement and Hepatic impairment studies (Ep. 22) Mar 25, 2024
    Show notes

    Today’s show is about hepatic impairment clinical studies. I cover the rationale behind evaluating hepatic impairment, common study designs, and key factors in the analysis and interpretation of the study results. I also share a huge announcement about Aplos NCA, a cloud-based solution for calculating NCA PK parameters. Use the link below to learn more about Aplos NCA.

    Links discussed in the show:

    • FDA guidance
    • EMA guideline
    • Aplos Analytics website
    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

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